Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT06559657
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2024-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Consistency Between Innovative Methods for Measuring the Area and Depth of Pressure Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound area measurment', 'timeFrame': 'Approximately 5 minutes until the wound is selected and the measurement is completed.', 'description': 'It is the measurement of wound area with three different methods.'}, {'measure': 'Wound depth measurment', 'timeFrame': 'Approximately 5 minutes until the wound is selected and the measurement is completed.', 'description': 'It is the measurement of wound depth with two different methods.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pressure Ulcer'], 'conditions': ['Pressure Injury', 'Innovativeness', 'Wound']}, 'referencesModule': {'references': [{'pmid': '28852954', 'type': 'RESULT', 'citation': 'Magny E, Vallet H, Cohen-Bittan J, Raux M, Meziere A, Verny M, Riou B, Khiami F, Boddaert J. Pressure ulcers are associated with 6-month mortality in elderly patients with hip fracture managed in orthogeriatric care pathway. Arch Osteoporos. 2017 Aug 29;12(1):77. doi: 10.1007/s11657-017-0365-9.'}, {'pmid': '34544270', 'type': 'RESULT', 'citation': 'Anisuzzaman DM, Wang C, Rostami B, Gopalakrishnan S, Niezgoda J, Yu Z. Image-Based Artificial Intelligence in Wound Assessment: A Systematic Review. Adv Wound Care (New Rochelle). 2022 Dec;11(12):687-709. doi: 10.1089/wound.2021.0091. Epub 2021 Dec 20.'}, {'pmid': '34605185', 'type': 'RESULT', 'citation': 'Tervo-Heikkinen TA, Heikkila A, Koivunen M, Kortteisto TR, Peltokoski J, Salmela S, Sankelo M, Ylitormanen TS, Junttila K. Pressure injury prevalence and incidence in acute inpatient care and related risk factors: A cross-sectional national study. Int Wound J. 2022 May;19(4):919-931. doi: 10.1111/iwj.13692. Epub 2021 Oct 4.'}, {'pmid': '28447852', 'type': 'RESULT', 'citation': 'Tubaishat A, Papanikolaou P, Anthony D, Habiballah L. Pressure Ulcers Prevalence in the Acute Care Setting: A Systematic Review, 2000-2015. Clin Nurs Res. 2018 Jul;27(6):643-659. doi: 10.1177/1054773817705541. Epub 2017 Apr 27.'}, {'pmid': '19661849', 'type': 'RESULT', 'citation': 'Little C, McDonald J, Jenkins MG, McCarron P. An overview of techniques used to measure wound area and volume. J Wound Care. 2009 Jun;18(6):250-3. doi: 10.12968/jowc.2009.18.6.42804.'}, {'pmid': '29244972', 'type': 'RESULT', 'citation': 'Khong PCB, Yeo MSW, Goh CC. Evaluating an iPad app in measuring wound dimension: a pilot study. J Wound Care. 2017 Dec 2;26(12):752-760. doi: 10.12968/jowc.2017.26.12.752.'}, {'pmid': '15230830', 'type': 'RESULT', 'citation': "Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x."}, {'pmid': '33095125', 'type': 'RESULT', 'citation': 'Pena G, Kuang B, Szpak Z, Cowled P, Dawson J, Fitridge R. Evaluation of a Novel Three-Dimensional Wound Measurement Device for Assessment of Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2020 Nov;9(11):623-631. doi: 10.1089/wound.2019.0965. Epub 2019 Oct 23.'}, {'pmid': '40346762', 'type': 'DERIVED', 'citation': 'Sahbudak G, Gunes U. Comparing Digital, Mobile and Three-Dimensional Methods in Pressure Injury Measurement: Agreement in Surface Area and Depth Assessments. J Clin Nurs. 2026 Jan;35(1):172-181. doi: 10.1111/jocn.17813. Epub 2025 May 9.'}]}, 'descriptionModule': {'briefSummary': 'Wound healing is a complex process and wound care and evaluation is one of the most important problems in current medicine. Wounds are seen in clinics as diabetic foot ulcers (DFU), arterial and venous ulcers, pressure injuries, surgical wounds and so on. Pressure injuries (PI) have a high mortality rate (29%) among elderly individuals. The prevalence of PIs in different countries worldwide varies between 6% and 18.5% in acute care settings. Wound assessment is an integral part of nursing practice.\n\nImproper assessment of wounds may lead to inadequate wound care, resulting in delayed wound healing, increased risk of infection, increased costs, and decreased patient quality of life. Wound measurement is a useful quantitative finding in wound assessment, used as a practical approach to monitor wound healing. An ideal wound measurement method should be practical, comfortable for the patient, high accuracy, reliability and applicability. In clinical practice, it is essential to regularly reassess wounds to monitor changes in size, depth, and appearance over time.\n\nWith the emergence of new techniques and technologies, there is a need for methods that can be considered as the gold standard in the measurement of wound dimensions. It is seen in the literature that studies comparing two- and three-dimensional measurement methods are generally carried out on superficial wounds and very limited wound types. In addition, there are hardly any studies comparing depth measurements with three-dimensional methods. In this direction, it was necessary to conduct this study in order to create evidence-based data in the field. The research has the quality of being the first and original study in our country that evaluates the compatibility of innovative methods in the area measurement of PIs and measures the wound depth.', 'detailedDescription': 'Hypotheses H1: There is concordance between digital planimetry and the imitoMeasure mobile application in measuring wound area.\n\nH2: There is concordance between digital planimetry and three-dimensional wound area measurement in measuring wound area.\n\nH3: There is concordance between the imitoMeasure mobile application and three-dimensional wound area measurement in measuring wound area.\n\nH4: There is concordance between measurement with a sterile cotton swab and three-dimensional wound measurement in assessing wound depth.\n\nAim: The aim of this study is to examine the concordance between digital planimetry, the imitoMeasure mobile application, and three-dimensional wound measurement methods in measuring the area of pressure injuries, and to compare the measurement of wound depth using a sterile swab with the three-dimensional wound measurement method.\n\nResearch Place and Time: This study was conducted between April 2022 and April 2024 in the intensive care unit of the Department of Anesthesiology and Reanimation at Ege University Medical Faculty Hospital.\n\nData Collection:\n\nFor the purpose of data collection in this study, the following were used: the "Individual and Wound Identification Form," the "Informed Consent Form," the "Digital Planimetry Device (Visitrak™)," the "Smith \\& Nephew Opsite Flexigrid Transparent Wound Dressing," the "imitoMeasure mobile application (iPhone 13)," the "eKare inSight device," and a "Sterile Cotton Swab."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years or older\n* Volunteering to participate in research,\n* Having at least Stage 2 pressure injury\n\nExclusion Criteria:\n\n* Having Stage 1 pressure injuries\n* Having a wound with a shape that makes 2D area measurement impossible\n* Patients who cannot remain in the same position for a long time'}, 'identificationModule': {'nctId': 'NCT06559657', 'briefTitle': 'Investigation of the Consistency Between Innovative Methods for Measuring the Area and Depth of Pressure Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Investigation of the Compatibility Among Innovative Methods in Measuring the Area and Depth of Pressure Injuries', 'orgStudyIdInfo': {'id': 'Nursing Faculty'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wound area and depth measurement', 'description': 'The area of the pressure injuries was measured using digital planimetry, the imitoMeasure mobile application, and the three-dimensional wound measurement method. Depth was measured using a sterile cotton swab and the three-dimensional wound measurement method.', 'interventionNames': ['Device: eKare Insight, imitoMeasure Mobile App, Visitrak']}], 'interventions': [{'name': 'eKare Insight, imitoMeasure Mobile App, Visitrak', 'type': 'DEVICE', 'description': 'The wound size of the patients was measured with three different methods. Wound depth was measured using manual method and three-dimensional imaging devices.', 'armGroupLabels': ['Wound area and depth measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'state': 'Bornova', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant at the Department of Nursing Principles', 'investigatorFullName': 'Gul SAHBUDAK', 'investigatorAffiliation': 'Ege University'}}}}